Citation

Galstyan G, Makarova P, Parovichnikova E, Kuzmina L, Troitskaya V, et al. (2018) The Results of the Single Center Pilot Randomized Russian Clinical Trial of Mesenchymal Stromal Cells in Severe Neutropenic Patients with Septic Shock (RUMCESS). Int J Blood Res Disord 5:033. doi.org/10.23937/2469-5696/1410033

Copyright

© 2018 Galstyan G, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

ORIGINAL ARTICLE | OPEN ACCESS DOI: 10.23937/2469-5696/1410033

The Results of the Single Center Pilot Randomized Russian Clinical Trial of Mesenchymal Stromal Cells in Severe Neutropenic Patients with Septic Shock (RUMCESS)

Gennadiy Galstyan*, Polina Makarova, Elena Parovichnikova, Larisa Kuzmina, Vera Troitskaya, Eduard Gemdzhian and Valeriy Savchenko

National Research Center for Hematology, Moscow, Russia

Abstract

Purpose

To investigate the safety of the of bone marrow-derived human multipotent mesenchymal stromal cells (MMSCs) administration in neutropenic patients with septic shock.

Methods

A single center prospective randomized Russian clinical trial of MMSCs in neutropenic patients with septic shock was registered (RUM–°ESS) (NCT 01849237). The patients were randomly assigned to receive conventional therapy (CT) (n = 15) or intravenous MMSCs + CT (n = 15) at the dose of 1 × 106 MMSCs/kg.

Results

Initial SOFA scores were 15.9 (95% CI 13.9-20.2) in MMSCs + CT and 16.1 (95% CI 12.1-19.0) in CT group. For second day cardiovascular component of SOFA and PaO2/FiO2 improved in MMSC + CT group. 28-days survival rates were 20% (3/15 patients) in CT group and 60% (9/15 patients) in the MMSC + CT group (P < 0.05). In MMSC + CT group only 4 patients remained alive in 3 months, 5 patients died due to the infection related organ dysfunctions, in CT group 3 patients remained alive in 3 months.

Conclusions

Administration of MMSCs in neutropenic patients with septic shock was well tolerated and attributed to the faster hemodynamic stabilization, vasopressor withdrawal, attenuation of respiratory failure and shortening of the neutropenia duration period.